Strengthening Tobacco 21 implementation and enforcement to reduce tobacco-related health disparities: A stakeholder engagement project

INTRODUCTION As a part of a priority-setting stakeholder engagement project to strengthen the impact of the federal Tobacco 21 (T21) law, we conducted a qualitative study to solicit input from a nationwide sample of tobacco control stakeholders regarding the implementation, enforcement, and equity implications of the T21 law. METHODS Following the T21 policy evaluation guidance developed by the Centers for Disease Control (CDC), we identified T21 experts in four domains: policy, evaluation, subject matter, and implementation from a national search of stakeholders (invitations, n=1279) to account for geographical variation. This study presents results from five focus groups conducted in December 2021 among stakeholders (n=31) with experience in T21 policy, evaluation, subject matter, and implementation. RESULTS Participating T21 stakeholders reported on eight themes from four main topic areas: 1) Implementation, 2) Enforcement, 3) Equity outcomes, and 4) Recommended changes from stakeholders. Stakeholders shared insights on both passive and active implementation methods used in their communities, and highlighted major barriers such as the absence of a standardized tobacco retail licensing mandate and insufficient resources. Regarding T21 enforcement, stakeholders believed that current deterrents for retail violations might not be effective. They noted that vape and tobacco shops and online sales of tobacco products are emerging major challenges in T21 enforcement. Stakeholders also discussed possible health inequities that may be exacerbated by heterogenous implementation of the T21 law. CONCLUSIONS To strengthen T21 and mitigate potential exacerbation of existing health inequities, greater alignment of federal, state, and local efforts to reduce heterogeneity of implementation and enforcement of the T21 law is recommended.

Most existing literature on T21 implementation, enforcement and outcomes has centered around the effectiveness of T21 policy with mixed results [5][6][7][8][9][10][11][12][13] . Researchers have raised concern that the potential public health benefits of the law might be weakened by deficiencies in enforcement measures. Further research has found that MLSA restrictions are 'not likely to be effective without significant ageverification requirements and increases in the number of and frequency of compliance checks that the FDA conducts' 14 .
There is a growing body of literature on best practices, assessment tools and policy logic models aimed at improving T21 outcomes 13,15,16 . To begin assessing adherence to model policies across the nation, Dobbs et al. 13 created a T21 policy assessment tool to evaluate the language used in state T21 implementation and enforcement laws. Their study found that across 16 US states, laws 'varied widely' in terms of 'key policy components' such as inspection policies, penalties for retail violations, and retail licenses. As the federal law does not mandate specific enforcement measures, such as the number of times a retailer is checked, more research is needed to understand how to best strengthen the T21 law across the nation to reach the maximum effect.
Along with the overall impact on underage tobacco use, the potential impact of T21 on health equity has also been the subject of an emerging body of research. While the 'piecemeal passage of T21 laws at the local and state levels was cause for concern from a health equity perspective', researchers note that the national T21 law has the potential to reduce tobacco use disparities throughout the nation 17 . Although the federal T21 law does not include provisions about Purchase, Use, and Possession (PUP) laws, which penalize minors for possession of a tobacco product, nor how states enforce T21 under civil or criminal law, both areas are causes for concern in terms of exacerbating inequities among communities that have been historically over-policed and have disproportionate levels of tobacco use 16 .
While great strides are being made in the attempt to strengthen T21, more research is needed to understand the barriers experienced by stakeholders to implement and enforce T21 in their localities. Voices of stakeholders are necessary for understanding the unique challenges faced in each locality and identifying potential resources to strengthen T21. The purpose of this study is to add to the existing literature on T21 implementation, enforcement and outcomes through exploring the viewpoints of a nationwide group of T21 stakeholders.

Stakeholder engagement project
We followed the policy evaluation guidelines developed by the Centers for Disease Control and Prevention (CDC) 18 . This stakeholder engagement project leveraged multiple methods, including a quantitative survey (n=246, Stage 1) and qualitative analysis of focus groups with stakeholders (n=31, Stage 2) and the general public (n=80, Stage 3) as three separate projects. This article presents Stage 2 results from five focus groups conducted in December 2021 with stakeholders (n=31) who had experience in T21 implementation and enforcement and who had completed the survey regarding T21 practices in their communities.

Sample recruitment
To ensure that the sample included T21 stakeholders with knowledge of and experience with the federal T21 law, we used a purposive sampling strategy. The research team conducted an extensive online search for tobacco coalitions, T21-related organizations, prominent national tobacco control conferences, and tobacco control policy research symposiums to identify stakeholders. In October 2021, our team sent 1279 initial invitation emails asking participants to complete a survey on their opinions of various tobacco control policies. Individuals identified as stakeholders in one or more categories were invited to participate in the study, including policy experts, evaluation experts, subject matter experts, and implementers (Supplementary file Table 1 Tables 2 and 3) for sample characteristics, detailed focus group procedure, and interview constructs.

Analysis
All focus groups were recorded and transcribed by a professional third-party transcription service, 'Transcribe Me' 19 . To ensure the quality of the transcriptions, a research team member checked each transcript for accuracy while watching recordings of each focus group. Minimal changes to correct spelling or instances of cross-speak were made. Then, two members of the research team read through each transcript to develop an initial codebook. Afterward, they independently coded all transcripts and returned to review each for agreement, resolve inconsistencies, and update the codebook. Another coding pass was completed using the updated codebook to conduct a thematic analysis of the data. These themes were presented to other members of the research team to discuss and review evidence associated with each theme. We employed the Consolidated Criteria for Reporting Qualitative Research (COREQ) framework (Supplementary file Table 4) to present study findings. Data for the initial survey where participants expressed interest in participating in a focus group were collected and managed using research electronic data capture (REDCap) tools 20,21 hosted at University of Nebraska Medical Center.

RESULTS
A total of 31 participants from across the nation attended five online focus groups in December 2021. Focus group participants were from 16 different US states and were assigned to a focus group based on scheduling convenience (Supplementary file  Table 2). Participants had the option to self-identify in more than one T21 stakeholder category. As a result, 17 participants identified as subject-matter experts (54.8%), 12 as policy experts (38.7%), five as evaluation experts (16.1%), four as implementation staff (12.9%), and four as 'other' (12.9%). Eight themes resulted from the analysis of four T21 topical areas: 1) Implementation, 2) Enforcement, 3) Equitable outcomes, and 4) Recommended changes from stakeholders. Table 1 shows two themes associated with T21 implementation.

Theme 1: Passive and active education strategies
Participants reported a variety of strategies used to raise awareness and educate about the passage of the federal T21 law. Although the majority of stakeholders described the importance of both passive and active strategies to reach this goal, most stakeholders reported the use of passive strategies that required minimal to no contact with retailers or the public, such as posting and distributing signage to tobacco retailers, disseminating retailer toolkits, and sharing written educational materials, such as brochures.
Active strategies that required face-to-face or virtual contact with retailers or the public included retailer education efforts and attempts to directly reach out to tobacco retailers. Retailer education efforts varied regarding how education programs were delivered, when they were offered, and by whom. Stakeholders named local health departments, local governmental offices, and local law enforcement agencies as the organizations responsible for retailer education in their respective communities.

Theme 2: Significant barriers to Tobacco 21 implementation
Funding and resource limitations Most stakeholders cited a lack of funding and resources as a common barrier to T21 implementation in their communities for both the passive and active strategies mentioned above (Focus group 4).

Lack of state tobacco retail licenses
Many stakeholders also highlighted the absence of a statewide licensing system as a common barrier to T21 implementation, as stakeholders were unable to access a comprehensive list of tobacco retailers in their area. Stakeholders had to compile and rely on lists of retailers that were often incomplete or possibly outdated due to fluctuations in the market. As one stakeholder described: 'It's kind of a mess how they put it [different state lists of tobacco retailers] together.' (Focus group 1) Accessibility and format of retailer trainings Challenges associated with tobacco retailer education efforts included accessibility and format of retailer training. A few stakeholders described a need for virtual or digital options in addition to in-person training. Business owners were challenged with high employee turnover rates and ensuring adequate training for their staff. Virtual or digital options could be helpful. One participant noted: 'So maybe there is a need to produce an education video or some kind of education that retailers can use with all the new clerks that they're constantly hiring …' (Focus group 4) When online training was available, several stakeholders also noted that retailers were facing issues with engagement and accountability, stating that it was difficult to tell if the employees were engaging with the material or simply clicking   Table 2 summarizes three themes associated with T21 enforcement with example quotes from stakeholders.

Theme 3: Large variation in enforcement measures and protocols
Discussion around current enforcement measures focused on retail compliance check protocols and penalties when a retailer was found to be in violation of the T21 law. As stakeholders represented a diverse array of communities, responses varied regarding compliance check protocols. The ages of covert buyers ('decoys') to conduct retailer compliance checks varied greatly by community. Some stakeholders reported cooperating individuals as young as 15 years old being used to conduct compliance checks (Focus  The frequency and distribution of retail compliance checks differed by community as well. Stakeholders reported annual, biannual, and sometimes even lower frequency compliance checks in their communities. Recurring visits for retailers found in non-compliance also depended on locality. One stakeholder from Colorado outlined their retail compliance policy to be twice a year, but mentioned: 'There's a handful of states that do twice a year, once a year minimum with a 24 to 36 month look-back period.' (Focus group 2) At the same time, stakeholders from other localities reported not having a 'look-back' policy, a policy in which an establishment with a prior violation is monitored for future violations and issued more severe penalties for repeated violations. Policies regarding frequency and distribution of checks included planned routes that reduced mileage for enforcement personnel, checking all retailers within a jurisdiction, or checking a sample of all retailers within an enforcement agency's jurisdiction.
Agencies tasked with conducting retail compliance checks depended on the stakeholder's locality as well. Agencies mentioned in our focus groups included local law enforcement agencies, local health departments, local tobacco control coalitions, FDA contracted partners, and Synar reporting agencies through the Substance Abuse and Mental Health Services Administration (SAMSHA). Stakeholders noted that while each state had FDA contractors and Synar reporters, state and local agencies varied. They noted that penalties for non-compliance or retail violations also depended upon locality. Current penalties reported included monetary fines given to business owners and clerks, loss or temporary suspension of tobacco retail license, or diversion programs in lieu of monetary fines.

Theme 4: Emerging areas of enforcement facing major challenges
Stakeholders described two emerging issues as major challenges in T21 enforcement: 1) vape and tobacco shops, and 2) online sale of tobacco products. Vape and tobacco shops are a concern for T21 stakeholders for a number of reasons, including differences in regulation of these shops. As one stakeholder explained: 'We do not visit them as a tobacco merchant retailer, because in Missouri, electronic cigarettes are not regulated like other tobacco products.' (Focus group 1) Online tobacco sales, including the use of social media, was another emerging concern. Stakeholders commented on the relative ease and access to purchase tobacco among youth and reported limited gate-keeping procedures in the online space, including both online retailers and on social media, to verify the purchaser's age (Focus group 1). Another concern associated with the online sale of tobacco was the complexity introduced by the online space in terms of who is responsible for enforcing MLSA and how such measures should be enforced.

Theme 5: Current FDA and SYNAR compliance efforts are insufficient
When discussing federal efforts to enforce T21, most stakeholders believed that current efforts through the FDA and the SAMHSA Synar program were insufficient, as their efforts were largely siloed in communities and the frequency, pattern, and penalties associated with their compliance checks were inadequate. Many stakeholders reported a gap between the FDA's enforcement efforts with other agencies involved in T21 enforcement. One stakeholder explained that the FDA compliance inspections did not match the current needs of their community (Focus group 1). Stakeholders believed that penalties were rarely issued by the FDA, and if issued, such efforts were not sufficient to deter future violations. Because of this, the onus of enforcement was often placed upon state organizations, as indicated by one stakeholder: 'In my opinion, nobody gets in trouble by the FDA when it comes to tobacco sales. I mean, it's really weak. It's really on the states to actually enforce it and protect their communities.' (Focus group 2) Table 3 shows one major theme centered around health equity emerging from discussions around the outcomes of the T21 law. Theme 6: Stakeholders are concerned about the potential implications of T21 on equity While some stakeholders believed that T21 had the potential to reduce health disparities among groups disproportionately affected by tobacco use by reducing youth tobacco initiation, other stakeholders expressed concern that T21 may have an unintended consequence of exacerbating discriminatory profiling of historically over-policed and marginalized groups. While the federal T21 law does not have provisions for PUP laws, which penalize underage buyers of tobacco products, stakeholders were concerned that localities that have state and local PUP laws would see an exacerbation of enforcement-based profiling in the wake of the T21 law. In addition to this concern, several stakeholders stated that the way penalties are enforced could have considerable impacts on equity, stating that T21 penalties should be enforced as a civil issue, rather than criminal. Table 4 displays two themes associated with stakeholders' recommended policy and procedural changes.

Theme 7: Changes in implementation and enforcement protocol are needed
When asked about what changes are needed to improve T21 implementation and enforcement, stakeholders gave several suggestions pertaining to retail compliance check protocols, retailer education efforts, and public engagement with T21. Stakeholders had mixed opinions on the frequency of retailer compliance checks. However, the majority cited that two or three times a year would be sufficient. Stakeholders believed that the individuals completing the checks needed to change from year to year and carry IDs. Stakeholders were split on the pattern of compliance checks as some advocated for random checks, while others advocated for propensity-based checks or more frequent checks for retailers near youth-serving institutions, such as schools. When asked who they thought should complete retail compliance checks, several stakeholders reported that local health departments would be ideal. However, in order for this to be effective, they would need to have the authority to issue penalties.
Several stakeholders believed that current retail education efforts were not tailored appropriately 'I mean, in theory, right, we're saying that if we prevent minority populations from having access to these products or using these products, that theoretically, over the years, their health outcomes will improve because we have less people using these products. What it will look like as we actually roll it out, I think it will be dependent on each community and whether or not they want to use it for profiling. ' (FG 4) '  and in order to be more effective, retail education must meet the needs of individual retailers based on the type of store and location. As explained by a stakeholder: '... having more understanding of individual needs of different retailers. We see that also in our area with vape retailers versus traditional tobacco retailers, but also with our varying needs, whether they're a QuikTrip or a mom-and-pop shop, or if they're rural versus our urban areas.' (Focus group 1) A final change that stakeholders mentioned was the need to engage and increase enforcement agency and community buy-in for the T21 law. Stakeholders believed that efforts to engage and educate enforcement agencies and communities about the importance of the T21 law were important.  that penalties for retail violations needed to be effective deterrents and provided suggestions of what they believed would be the most effective. In areas where tobacco retail licenses were issued, the majority of stakeholders believed that an effective policy would be to suspend the license in the first offence and then revoke the license in the case of repeated offences. In terms of monetary penalties, stakeholders believed that the fines needed to be large enough to act as a deterrent.
Stakeholders strongly advocated that in the case of a retail violation, any monetary fine should be charged to the owner of the business rather than the clerk that sold the tobacco product. It was also suggested that if a retail violation was made, rather than a monetary fine, the clerk should be offered the opportunity to complete a retailer education diversion program. In practice, some stakeholders suggested that a monetary fine for the business owner and the option to attend a diversion program in lieu of a monetary fine for the clerk, should be assessed and compared for effectiveness.

DISCUSSION
The findings of this study provide an emic view of the strategies and challenges of T21 implementation, enforcement and outcomes from a diverse body of T21 stakeholders. To our knowledge, this is the first study examining stakeholder attitudes toward T21 implementation and enforcement. The majority of methods used by stakeholders were passive strategies, which may signify the need to incorporate more active education strategies, such as direct outreach to tobacco retailers, that could be supplemented with current educational materials. The findings from this study suggest further evaluation is needed of the different retailer education strategies, including how to improve current education programs, such as the inclusion of adult learning principles or tailored retailer education offered in several modalities (inperson, videos, e-modules). Most stakeholders also identified a lack of funding and the need for increased public awareness as barriers to their education and awareness goals. Furthermore, customized educational resources are imperative for different communities, in addition to widely applicable initiatives like the FDA's 'This Is Our Watch' program 22 . This gap can be filled by additional support from the federal level, including funding for items such as custom signage tailored to a specific community's needs as well as national efforts to raise public awareness of the T21 law.
Barriers to implementation identified by stakeholders also included state and local laws inconsistent with federal law and a lack of statewide retail licenses, both of which need to be addressed and revised at the policy level. Competing laws could result in confusion as retailers were required to post signage that had conflicting information, and local communities were unsure of which law was, in fact, the superseding law. As federal law supersedes state and local laws, state and local laws should have updated MLSAs to reflect the national minimum age of 21 years to eliminate any confusion caused by competing laws. Similarly, in order to effectively regulate T21 enforcement, comprehensive lists of tobacco retailers must be readily available, which most stakeholders identified as a key resource needed in order to properly implement T21 in their communities. While prior studies have been conducted to successfully determine the total number of tobacco retailers within a state that did not have a tobacco licensing law, statewide tobacco retail licensing laws would ensure each state would have a standardized list of all retailers as well as facilitate further regulation of retail violations when necessary 23 . Currently, 29 US states have instituted mandatory tobacco retailer licenses, which have been shown to reduce youth tobacco use and youth e-cigarette initiation [24][25][26][27] .
Vape and tobacco shops are areas of particular concern for T21 enforcement because e-cigarettes are not regulated similarly to other tobacco products. The online space was also mentioned as a major concern for enforcement as youth under the age of 21 years use e-cigarettes more than any other tobacco product and are most likely to purchase their e-cigarette devices either in vape shops or online. Further study and policy development responding to the challenges in regulating online retailers is important 28,29 .
While not explicitly framed as an issue of equity by stakeholders, equity concerns were raised around penalties incurred by the clerk or retailer in businesses where a retail violation took place. From an equity perspective, while monetary fines would need to be enough to deter future retail violations, Tob. Prev. Cessation 2023;9(June):20 https://doi.org/10.18332/tpc/163299 the size of the business in question may also need to be taken into consideration as a single locally owned business may not have similar resources as larger chain retailers.

Limitations
There are limitations to note. First, participants of these focus groups represented 16 US states, which, given the variability of T21 implementation and enforcement based on location, may have influenced the results of this study. Second, 10 participants (32.3%) resided in Nebraska, which may have introduced a geographical bias in the results of this study. To minimize geographical bias, participants from differing states were encouraged to provide their unique perspectives. Third, we did not analyze results based on participant characteristics, such as their location or stakeholder category; however, this should be considered in future studies with large sample sizes.

Implications
T21 implementation and enforcement varied based both on state and local policies as well as locally available resources. Most stakeholders predominantly employed passive strategies, lacking direct interaction with tobacco retailers or the general public. This suggests that there may be a necessity to adopt more active strategies that involve direct engagement with retailers. Policy changes to strengthen and align federal, state, and local efforts are needed to reduce barriers in T21 implementation and enforcement, and proactively identify and mitigate the exacerbation of existing health inequities.

CONCLUSIONS
While the T21 law has been estimated to save over 230000 lives, key stakeholders have identified barriers threatening to weaken its impact across the United States. Our findings will allow additional research and policy development to strengthen and improve the impact on public health of the Tobacco 21 law. While T21 will not be a panacea for reducing youth tobacco use, reducing barriers to its implementation and enforcement could strengthen its impact.